Cardiovascular Function in Sub Maximal Exercise and Performance in Three Daily Activity Tests After Stroke

NCT01396746 | Unknown DMC

• 1 other identifier: 54-2011
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore the relationship between cardiovascular function of persons with post stroke conditions and their performance in three field tests. This is a validation study, aiming to determine during which of two activities VO2 measurements better express the functional restrictions caused by stroke, And to find out whether the Total Heart Beat Index can be used in the case of stroke survivors for the prediction of mechanical efficiency when measured during stair-climbing and of energy cost during treadmill walking. The hypothesis is that Stair Climbing (STC) is a more suitable form of exercise capacity testing compared to Treadmill Walk (TMW) since it potentially requires a greater amount of external work, and therefore will show stronger correlation with functional tests demonstrating the same ability, whereas TMW does not utilize the movement capability of participants to the fullest. Another hypothesis is that cardiac response to the exertion can be used as a predictor of those measures during these exertions in the post stroke population.

Conditions

Stroke; Hemiplegia

Outcome Measures

Primary Outcomes (6)

• Exercise VO2

  60 days

• Exercise HR

  60 days

• Mechanical efficiency

  60 days

• Time for-Up-and-go (TUG) Test

  60 days

• Time for 10 m walk test

  60 days

• Distance for 6 min walk test

  60 days

Study Arms (1)

People with Post Stroke Conditions

(a) having acquired stroke at least 1 year before testing. (b) Chronic weakness and/or spasticity of the affected side. (c) Independent stair-climbers (with hand-rail). (d) With cognitive level sufficient to comprehend instructions. (e) age range between 40-69. (f) Use of walking aid is permitted as long as the participant is able to walk on a treadmill with hand-rail. (g) No heart failure or other medical conditions that preclude participation in the study.

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants are recruited in community centers designated for Disabled populations. They are leading a physically active life style, usually facilitated by an assistant.

You may qualify if:

• Having acquired stroke at least 1 year before testing
• Chronic weakness and/or spasticity of the affected side
• Independent stair-climbers (with hand-rail)
• Received medical clearance from a physician
• With cognitive level sufficient to comprehend instructions
• Participants' age will range between 40-69
• Use of walking aid is permitted as long as the participant is able to walk on a treadmill with hand-rail.

You may not qualify if:

• Unable to understand instructions
• Unable to ambulate
• Severe aphasia
• Heart failure or other medical conditions that preclude participation in the study.

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead
• Zinman College of Physical Education and Sports Sciences: collaborator
• Israel Sport Center for the Disabled: collaborator

Study Sites (1)

Israel Sport Center for the Disabled

Ramat Gan, Israel

RECRUITING

Related Publications (46)

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MeSH Terms

Conditions

Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yeshayahu Hutzler, Dr.

  The Wingate institute for physical education and sports

  STUDY CHAIR

• Avraham Katz, MD

  Israel Sport Center for the Disabled

  PRINCIPAL INVESTIGATOR

• Galia Modai

  The Wingate Institute for Physical Education and Sports

  STUDY DIRECTOR

Central Study Contacts

Galia Modai

CONTACT

972-54-6477737; galiamodai@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: June 28, 2011
• First Posted: July 19, 2011
• Study Start: June 1, 2011
• Last Updated: July 19, 2011

Record last verified: 2011-07

Locations

IL (1)